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    Letrozole May Cut Risk of Breast Cancer

    by: Darrin Kiessling

    10/10/2003

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    Health officials recently halted a large international study after an early review of the results suggested that the anti-estrogen drug letrozole dramatically reduces the risk of recurrence of cancer among of breast cancer survivors.

    About 211,300 new cases of breast cancer are expected to be diagnosed this year in the United States , two-thirds of them in women who have gone through menopause. Most tumors will be estrogen-receptor positive, meaning that the hormone fuels their growth.

    The standard treatment for breast cancer is surgery, radiation and/or chemotherapy, followed by five years of tamoxifen, which helps keep estrogen from entering cells. Research has shown, however, that women gain no additional benefits after they take tamoxifen for five years, and that it may increase women's risk of endometrial cancer, pulmonary embolism, and stroke.

    The study, led by Dr. Paul Goss of Toronto 's Princess Margaret Hospital , involved 5,187 women at hundreds of medical centers in the United States , Canada and Europe . Half the women in the study were randomly assigned to take letrozole. The others took placebo pills. An average of 2.4 years after their tamoxifen treatment ended, 132 (13 percent) women who were taking placebos developed new breast cancer or recurrences of their original cancer, compared with 75 (7 percent) among women taking letrozole who had a recurrence.

    The study was supposed to follow the women for five years after they had finished with tamoxifen treatments, to see if letrozole was better than a placebo during that period. But when an independent committee reviewed the results early, the treatment was deemed so successful that the study was immediately halted and it was decided that all the women taking part in the study should be given the drug.

    Letrozole, made by Novartis and sold under the trade name Femara ®, is one of a new group of anti-estrogen medications called aromatase inhibitors. The other aromatase inhibitors currently on the market are anastrozole, which AstraZeneca sells as Arimidex ®, and exemestane, which Pfizer sells as Aromasin ®.

    Aromatase inhibitors work by stop production of estrogen by blocking the enzyme aromatase, which converts other hormones into estrogen. Therefore they are not seen as entirely benign -- because these drugs hinder estrogen production at its source, they may reduce blood levels of estrogen by 95 percent or more. This also raises the risk of osteoporosis and can cause hot flashes and night sweats.

    The study results, along with two editorials, will be published in the November 6, 2003, issue of The New England Journal of Medicine, but the journal published them early on October 9 because of their importance.


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